Journal article

Pembrolizumab plus chemotherapy as neoadjuvant treatment of high-risk, early-stage triple-negative breast cancer: results from the phase 1b open-label, multicohort KEYNOTE-173 study

P Schmid, R Salgado, YH Park, E Munoz-Couselo, SB Kim, J Sohn, S-A Im, T Foukakis, S Kuemmel, R Dent, L Yin, A Wang, K Tryfonidis, V Karantza, J Cortes, S Loi

ANNALS OF ONCOLOGY | ELSEVIER | Published : 2020

Abstract

BACKGROUND: The phase Ib KEYNOTE-173 study was conducted to assess the safety and preliminary antitumor activity of neoadjuvant chemotherapy plus pembrolizumab in high-risk, early-stage, non-metastatic triple-negative breast cancer (TNBC). PATIENTS AND METHODS: Six pembrolizumab plus chemotherapy regimens were evaluated (cohorts A-F). All cohorts received a pembrolizumab 200-mg run-in dose (cycle 1), then eight cycles of pembrolizumab in combination with a taxane with or without carboplatin for 12 weeks, and then doxorubicin and cyclophosphamide for an additional 12 weeks before surgery. Primary end points were safety and recommended phase II dose (RP2D); secondary end points were pathologic..

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Grants

Funding Acknowledgements

This work was supported by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. (no grant number applicable). This study was administered and sponsored by Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc. The study was designed by the academic authors in conjunction with Merck & Co., Inc., Kenilworth, NJ, USA representatives. Data were collected by the sponsor and analyzed in collaboration with the authors. All authors had access to the data and vouch for its accuracy and completeness. A medical writer contracted by the sponsor provided assistance in preparing the report. All authors were involved in the decision to submit the manuscript for publication.